New drug applications approved by US FDA as of 16 - 30 April 2019 which includes New Molecular Entities (NMEs) and new biologics. It
does not include Tentative Approvals. Supplemental approvals may have
occurred since the original approval date.

Use of partially hydrolysed infant formula reduces risk of atopic dermatitis in infants

“In healthy Singapore infants with a family history of allergy who are not exclusively breastfed, the strategy of using PHF-W as a short-term initial infant formula instead of CMF is expected, on average, to reduce AD burden, improve quality of life (QoL) and result in net cost savings,” researchers said.

From birth to month 30, the incidence and clinical/economic burden of AD in high-risk, nonexclusively breastfed infants with PHF-W or CMF for up to 4 months were simulated using modelling techniques. Epidemiologic and clinical data were obtained from a local comparative trial. AD treatment patterns and outcomes were informed by expert opinion.

Measure outcomes were as follows: AD risk reduction, time spent with AD, days without AD flare, quality-adjusted life years (QALYs) and direct/indirect costs. Model parameter uncertainty was evaluated using multivariate probabilistic sensitivity analysis.

Use of PHF-W vs CMF over 30 months resulted in a 16.0-percent decrease (28.3 percent vs 44.3 percent) in the proportion of children who developed AD and 6.4 months lesser time spent with AD. Furthermore, time without AD flare and QALYs improved by 14.9 days and 0.021 QALYs per patient, respectively. [Singapore Med J 2018;59:439-448]

This finding supports that of a 2002 study conducted by Chan and colleagues. [J Paediatr Child Health 2002;38:84-88]

Estimated AD-related discounted costs per child were also lower with PHF-W than with CMF (SGD 771 vs SGD 1,309; net savings, SGD 538). Compared with CMF, PHF-W was less expensive and more effective for 73 percent, and cost less than SGD 50,000 per QALY for 87 percent of all multivariate simulations.

The primary drivers of such savings were reductions in costs associated with pharmacotherapy, physician visits and indirect costs.

“Exclusive breastfeeding is the absolute gold standard for feeding infants. However, not all infants are able to receive exclusive breastfeeding in practice. When this is the case, formula feeding may be the second choice,” according to researchers. [Evid Based Med 2016;21:157]

In such circumstances, a short-term early nutritional intervention with PHF-W instead of CMF is recommended for infants with a family history of atopy, they noted.

“Given the results of our study and considering the controversy over the evidence on this topic, healthcare practitioners in Singapore should look beyond those at high risk due to having at least one first-degree family member with atopy,” researchers said.

“Other noneconomic factors that may impact the risk of allergic conditions, such as preterm birth and high infant weight gain, should be taken into consideration when determining, on an individual basis, the most appropriate choice of infant formula for use with high-risk infants who are not exclusively breastfed,” they added. [J Allergy Clin Immunol 2014;133:1317-1329]

New drug applications approved by US FDA as of 16 - 30 April 2019 which includes New Molecular Entities (NMEs) and new biologics. It
does not include Tentative Approvals. Supplemental approvals may have
occurred since the original approval date.